Senior Regulatory Adviser

Concept Foundation

Senior Regulatory Adviser

Concept Foundation

Europe

Description:

Concept Foundation is an NGO working in the field of quality of and access to reproductive and maternal health medicines in developing countries with offices in Geneva, Switzerland and Bangkok, Thailand.

We are looking for a Senior Regulatory Adviser to support the registration of a new maternal health drug worldwide. Our Client is a leading research-based multinational pharmaceutical company.

As part of the project team. your main duties will be to:

  • Collect and evaluate regulatory requirements to prepare regulatory strategy and timelines for submissions to multiple Regulatory Authorities;
  • Prepare regulatory submissions (e.g. registration dossier, variations, scientific advice submissions) for Regulatory Authorities, ensuring that submissions are of high quality and meet all regulatory requirements for smooth and fast approval;
  • Coordinate with the local agents for successful submissions and achievement of the Marketing Authorization/s;
  • Negotiate with Regulatory Authorities and other key stakeholders to facilitate regulatory approval;
  • Liaise with the manufacturers/clinical researchers and/or collect scientific literature data to compile clear arguments and responses to Regulatory Authorities’ questions and comments within the requested timeframe;
  • Provide expert advice about regulatory requirements for other related new products to Concept Foundation’s technical team and partner product manufacturers;
  • Keep up-to-date with changes in regulatory legislation and guidelines;
  • General regulatory and maintenance tasks.

Requirements:

  • University degree (Master’s degree or equivalent degree) in Science (e.g. Chemistry, Pharmacy, Regulatory Affairs or equivalent);
  • A minimum of 5 years’ experience in international drug regulatory affairs, preferably with drug registrations in e.g. Africa, CIS, Latin America, Asia –Pacific regions;
  • Knowledge of WHO and European pharmaceutical legislation, relevant guidelines, procedures and requirements;
  • Ability to interface with Regulatory Authorities and our Client;
  • Ability to travel and work in an international environment;
  • Good technical writing skills and ability to communicate effectively internally and externally in English;
  • Fluency in English is mandatory, knowledge of French language is desirable.

The candidate must be based in Europe and have a valid EU-25/EFTA citizenship. The organization is able to offer a flexible environment for the successful candidate where the Senior Regulatory Adviser is not domiciled in Switzerland.

Applications:

Interested applicants should send a CV to recruitment@conceptfoundation.org. Recruitment is open until position is filled.

Don't forget to mention EuroPharmaJobs when applying.

Share this Job

More Job Searches

Concept Foundation     Multiple Countries     Clinical Research     Regulatory Affairs     5 Years+ Experience    

© EuroJobsites 2019

EuroJobsites is a UK registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

Newsletter | Recruit | Advertise | Privacy | Contact Us

© EuroJobsites 2019

EuroJobsites is a UK registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

This website uses cookies to make your experience better. Continued use of this website means you accept our cookie policy.  Accept Cookies